Dataset Information

Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial.

ABSTRACT: BACKGROUND:Coordination of care, especially after a patient experiences an acute care event, is a challenge for many health systems. Event notification is a form of health information exchange (HIE) which has the potential to support care coordination by alerting primary care providers when a patient experiences an acute care event. While promising, there exists little evidence on the impact of event notification in support of reengagement into primary care. The objectives of this study are to 1) examine the effectiveness of event notification on health outcomes for older adults who experience acute care events, and 2) compare approaches to how providers respond to event notifications. METHODS:In a cluster randomized trial conducted across two medical centers within the U.S. Veterans Health Administration (VHA) system, we plan to enroll older patients (? 65?years of age) who utilize both VHA and non-VHA providers. Patients will be enrolled into one of three arms: 1) usual care; 2) event notifications only; or 3) event notifications plus a care transitions intervention. In the event notification arms, following a non-VHA acute care encounter, an HIE-based intervention will send an event notification to VHA providers. Patients in the event notification plus care transitions arm will also receive 30?days of care transition support from a social worker. The primary outcome measure is 90-day readmission rate. Secondary outcomes will be high risk medication discrepancies as well as care transitions processes within the VHA health system. Qualitative assessments of the intervention will inform VHA system-wide implementation. DISCUSSION:While HIE has been evaluated in other contexts, little evidence exists on HIE-enabled event notification interventions. Furthermore, this trial offers the opportunity to examine the use of event notifications that trigger a care transitions intervention to further support coordination of care. TRIAL REGISTRATION:ClinicalTrials.gov NCT02689076. "Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization." Registered 23 February 2016.

SUBMITTER: Dixon BE

PROVIDER: S-EPMC6611045 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial.

Dixon Brian E BE Schwartzkopf Ashley L AL Guerrero Vivian M VM May Justine J Koufacos Nicholas S NS Bean Andrew M AM Penrod Joan D JD Schubert Cathy C CC Boockvar Kenneth S KS

BMC medical informatics and decision making 20190704 1

<h4>Background</h4>Coordination of care, especially after a patient experiences an acute care event, is a challenge for many health systems. Event notification is a form of health information exchange (HIE) which has the potential to support care coordination by alerting primary care providers when a patient experiences an acute care event. While promising, there exists little evidence on the impact of event notification in support of reengagement into primary care. The objectives of this study ...[more]

PMID: 31272427

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Project description:ObjectivesTo compare 90-day postoperative complication rates between Veterans receiving cataract surgery in VA vs Community Care (CC) during the first year of implementation of the Veterans Choice Act.Data sourcesFiscal Year (FY) 2015 VA and CC outpatient data from VA's Corporate Data Warehouse (CDW) 10/01/14-9/30/15). FY14 data were used to obtain baseline clinical information prior to surgery.Study designRetrospective one-year study using secondary data to compare 90-day complication rates following cataract surgery (measured using National Quality Forum (NQF) criteria) in VA vs CC. NQF defines major complications from a specified list of Current Procedural Terminology (CPT) codes. We ran a series of logistic regression models to predict 90-day complication rates, adjusting for Veterans' sociodemographic characteristics, comorbidities, preoperative ocular conditions, eye risk group, and type of cataract surgery (classified as routine vs complex).Data collectionWe linked VA and CC users through patient identifiers obtained from the CDW files. Our sample included all enrolled Veterans who received outpatient cataract surgery either in the VA or through CC during FY15. Cataract surgeries were identified through CPT codes 66 984 (routine) and 66 982 (complex).Principal findingsOf the 83,879 cataract surgeries performed in FY15, 31 percent occurred through CC. Undergoing complex surgery and having a high-risk eye (based on preoperative ocular conditions) were the strongest clinical predictors of 90-day postoperative complications. Overall, we found low complication rates, ranging from 1.1 percent in low-risk eyes to 3.6 percent in high-risk eyes. After adjustment for important confounders (eg, race, rurality, and preoperative ocular conditions), there were no statistically significant differences in 90-day complication rates between Veterans receiving cataract surgery in VA vs CC.ConclusionsAs more Veterans seek care through CC, future studies should continue to monitor quality of care across the two care settings to help inform VA's "make vs buy decisions."

Project description:BACKGROUND:The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. METHODS/DESIGN:This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years. DISCUSSION:VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. TRIAL REGISTRATION:Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529.

Project description:BackgroundTherapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity.MethodsThis is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3-5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated.DiscussionIn this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19.Trial registrationClinicalTrials.gov NCT04397718. Registered on May 21, 2020.

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Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial.

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Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial.

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